We propose in vivo efficacy studies of candidate oncology therapies in xenograft or orthotopic tumor models using human or murine tumor cell lines. Human cancer cell lines are typically engrafted in immunocompromised mice such as nude mice. A typical study includes the following groups (5 mice per group):
Tumor-bearing mice are grouped to get homogenous tumor volume at the beginning of the study. The test item can be administered via the chosen route of administration (i.v., p.o., i.p., and s.c.) with different frequencies (for example once or twice a week). Animals are monitored 2 times per week for body weights, clinical observations, and tumor size (using digital calipers). Tumor volume (mm3) is calculated using the “(W x W x L) / 2” formula, where W is tumor width and L is tumor length.
The typical study duration is 60 days or until individual tumors reach a 1500 mm3 endpoint. Sample collection can be performed at the end of the study.